THE DONOR PROCESS

Our proprietary process begins with meticulous screening of the donor mother and father as well as family members for several generations. In addition to routine industry screens for bloodborne pathogens, we also screen for heritable and non-heritable conditions, environmental contaminants from medications, alcohol, drugs, tobacco, and electronic vaping. Only healthy families who meet or exceed these criteria are considered. Postnatal tissue donations are promptly collected from local hospitals specialists following a healthy cesarean birth. After processing, allografts are tested again to ensure they are free of contaminants or infection, and contain healthy, viable cells prior to cryopreservation.

We put families first

Our lots are quarantined for 14 days and thoroughly tested for bacterial, communicable and other disease contamination by a CLIA-certified lab. In addition, plate testing is conducted in multiple phases of the process to ensure zero contamination.

Diseases that are tested for donation eligibility:

  • Hepatitis Bs Ag
  • Hepatitis Bc Ab
  • HTLV I/II Ab
  • Hepatitis C Ab
  • HIV 1&2 Plus O Ab

  • CMV ab
  • RPR (Non-treponemal syphilis)
  • HIV-1/HCV/HBV NAT (Ultrio)
  • WNV NAT

Eligibility

Meticulous screening of donor mothers and fathers, as well as family members ensures product safety and viability.

Collection

A Recovery Specialist collects the postnatal donation at the designated hospital and returns the donation to be documented and processed.

Testing

All lots are quarantined for 14 days and thoroughly tested for bacterial and disease contamination by a CLIA certified lab.

Processing

Our proprietary process meets the FDA’s requirements of cells and tissues being minimally manipulated.


100% Chain of Custody

With collection of a healthy postnatal donation, complete and proper testing procedures, an FDA minimally manipulated process, and a unique cryopreservation method, you can rest assured we provide a safe and reliable product with a proven 100% Chain of Custody.

BWG only sells to licensed medical professionals.


Our products are sold to licensed medical professionals. All lots are prepared and distributed in full compliance with FDA regulations. BioWellness Group will continue to maintain its perfect 15 year safety record and its perfect 15 year record of excellence with the FDA.

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